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Mental State, Reported as Depression, Anxiety or StressEarly Phase 1NCT01169480

The Impact of Giving a Massage

A Early Phase 1 study testing Give a massage in people with Mental State, Reported as Depression, Anxiety or Stress, run by Parker Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to investigate if giving a massage impacts the mental state of a massage therapist, including depression, anxiety, and stress . It is speculated that feelings of depression, anxiety and stress will reduce following the giving of a massage. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
Give a massage
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
Jun 2010to Sep 2010
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy adults who are currently massage therapists, massage student or recent massage school graduates,
  • Aged 18 to 65 years,
  • Fluent in English

Who cannot join

  • Current bruising,
  • Fracture,
  • Inflammatory arthritides,
  • Peripheral neuropathy,
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Parker College School of Massage

    Dallas, Texas, 75229

Other trials in United States

About this study

Official title: The Impact of Giving a Massage on Perceived Depression, Anxiety and Stress of Massage Therapists: A Randomized Clinical Trial

The aim of this study is to investigate if giving a massage impacts the mental state of a massage therapist, including depression, anxiety, and stress . It is speculated that feelings of depression, anxiety and stress will reduce following the giving of a massage.

Read the detailed description

Background It is well established that massage is beneficial for musculoskeletal conditions such as low back pain1-3 and neck pain. In addition, massage has been shown to alleviate depressive symptoms and reduce state anxiety and perceived stress. Furthermore, the therapeutic benefits of touch itself are recognized for many conditions and in many stages of life.

Thus far all massage research has investigated the impact of massage on the massage client, or the receiver of the massage. No peer-reviewed study was found that reported any biopsychosocial effects on the giver of the massage, the massage therapist.

With touch therapies such as massage, it is impossible to touch without being touched oneself. Therefore, it is speculated that the giver of a touch therapy will also receive a therapeutic benefit. In fact, it has been reported anecdotally that massage therapists often feel "better" after they give a massage than before. Feelings of exhilaration, enhanced well-being, and improved energy are common.

The aim of this study is to investigate if giving a massage impacts the state of mind of massage therapists, including depression, anxiety, and stress.

Methods

Participants For this study, 22 participants who are massage therapists, students of massage or recent graduates will be recruited from the Parker School of Massage Therapy(PSMT). Participants will be included if they are healthy and aged between 18 and 65 years old, and excluded if they currently have any of the following conditions: contusion, fracture, inflammatory arthritides, peripheral neuropathy, or pregnancy. Of the eligible volunteers, ten participants will be randomly selected to the experimental group, while the other ten participants will act as controls. All interventions will occur in the PSMT.

Interventions Participants in the experimental group will be asked to give one 50-minute Swedish massage to another volunteer. Control participants will be asked to wait in a classroom (i.e. do nothing) for the same amount of time.

Objectives The aim of this study is to investigate if giving a massage impacts the mental state of a massage therapist, including depression, anxiety, and stress. It is speculated that feelings of depression, anxiety and stress will reduce following the giving of a massage.

Outcomes The primary assessment measure will be the Depression, Anxiety, Stress Scales (DASS). The DASS is a set of three self-report scales measuring the affective states of depression ("D"), anxiety ("A") and stress ("S"). Each of the 21 items is scored from "0" (Did not apply to me at all) to "3" (Applied to me very much or most of the time). A template is used to score the test and subscore is achieved for each of the three subcategories. Subscores can range from 0 to 28+, with normals being at the lower end of the range. The DASS was found to have adequate convergent and discriminant validity and good reliability, including test-retest reliability.

Secondary outcome measure will be the State-Trait Anxiety Inventory-II (STAI). The STAI is a self-report measure that assesses both state anxiety (i.e. feelings at present moment) and trait anxiety (i.e. general feelings). The 40 items are measured on a 4-point Likert scale (1=Almost Never to 4=Almost Always). Scores are obtained for each subscale (State and Trait Anxiety) with the higher scores indicating higher anxiety. The STAI has been shown to be valuable in both research and clinical settings, and has been found to have high internal consistency, and excellent test-retest reliability.

Sample Size Sample size estimation was performed based on the primary outcome measure, the DASS. A minimum change in the total DASS score of 10 points is predicted using results from a similar effectiveness studies. Using the DSS Research Sample Size Calculator Software http://www.dssresearch.com/toolkit/sscalc/size_a2.asp), and a 5% level of confidence a total of 22 participants (11 per group) would be required for a statistical power of 0.81. We do not anticipate any loss-to-follow up and thus have not made any further adjustment for attrition.

Randomization \& Blinding Participants meeting the eligibility criteria will be pooled and a random drawing will determine which individuals will be in the experimental group and give the massage and which will act as controls. An independent assistant will perform the randomization process. Another independent assistant who is blind to group allocation will administer the assessment measures. Participants will be blind to group allocation for the duration of the study. While it is very difficult to blind participants when hands-on therapies are investigated, in this study this will be accomplished because giving a massage is a routine part of the day for these participants.

Being tested
Give a massage
Keywords
Massage, Therapist, Massage, DASS, Depression, Anxiety, State, Anxiety, Trait, Stress, Touch, Therapeutic Relationship
Medical subject headings
Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Give a massageBehavioural

    Participants in this arm will give a 50-minute Swedish massage to a volunteer.

Study groups in NCT01169480
Study groupRoleWhat they receive
Massage GiverExperimentalParticipants in the experimental group will be asked to give one 50-minute Swedish massage to another volunteer.
Receives: Behavioral: Give a massage
Passive ControlsNo interventionParticipants in this arm will wait in a classroom (as usual) and do nothing out of their ordinary routines.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perceived, self-reported stress, anxiety and depression

    The primary assessment measure will be perceived, self-reported stress, anxiety and depression as measured by the Depression, Anxiety, Stress Scales (DASS). The DASS is a set of three scales measuring the states of depression, anxiety and stress. Each of the 21 items is scored from "0" (Did not apply to me at all) to "3" (Applied to me very much or most of the time). A subscore is achieved for each of the three subcategories. Subscores can range from 0 to 28+. The DASS was found to have adequate convergent and discriminant validity and good reliability, including test-retest reliability.

    Measured: Immediately before the 50-minute masage

Secondary outcomes (1)
  1. Perceived, self-reported state and trait anxiety

    Secondary outcome measure will be perceived, self-reported state and trait anxiety as measured by the State-Trait Anxiety Inventory-II (STAI). The STAI is a self-report measure that assesses both state anxiety and trait anxiety. The 40 items are measured on a 4-point Likert scale (1=Almost Never to 4=Almost Always). Scores are obtained for each subscale with the higher scores indicating higher anxiety. The STAI has been shown to be valuable in both research and clinical settings, and has been found to have high internal consistency,19 and excellent test-retest reliability.

    Measured: Immediately before the 50-minute massage

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionSep 2010
  4. Study completionSep 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01169480
Sponsor's protocol ID
Massage Study - I
Status last verified
Jun 2017
First submitted
26 Apr 2010
Last updated
20 Jun 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Give a massage in people with Mental State, Reported as Depression, Anxiety or Stress, run by Parker Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perceived, self-reported stress, anxiety and depression (time frame: Immediately before the 50-minute masage). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2017.

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